A Pilot Study of eHealth Tools in a Tertiary-care Setting

NCT ID: NCT03762460

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2022-12-31

Brief Summary

This feasibility study investigates the use of eHealth tools within routine medical treatment for patients with depression in an outpatient psychiatric setting. The study investigates whether patients find a mobile-optimized online eHealth tool to be acceptable and feasible, and whether clinical and functional outcomes improve with use of the online eHealth tool, compared to informational online resources for mental health.

Detailed Description

Major Depressive Disorder (MDD) is increasingly recognized as the most common psychiatric disorder and as one of the most common medical diagnoses worldwide.

Measurement-based care (MBC) is an evidence-based approach for providing effective clinical care to patients with MDD. MBC utilizes validated rating scales to assess symptom severity, functional impairments, treatment adherence, and side-effect burden to personalize clinical decision-making based on measured outcomes and clinical algorithms. However, despite evidence demonstrating improved outcomes, MBC is still not routinely used by physicians. Barriers to the use of MBC include lack of knowledge of which scales to use, how to incorporate measurements into clinical charting systems, and the extra time needed for repeated assessments.

Our research team developed a web-based application (app) optimized for mobile devices to address the treatment gap in MBC for people with depression, especially those who are working while depressed. This user-friendly eHealth tool encourages patients to actively participate in MBC by using their smartphones, tablets, or computers to screen, monitor, and manage depressive symptoms and functional outcomes. Results can be easily displayed and printed to share with clinicians, thereby affording health professionals a simple and cost-effective means to integrate MBC into standard practices and to optimize treatment for MDD at the point of care, without needing additional materials, equipment, or staffing.

This research study investigates the feasibility of using a mobile-optimized online eHealth tool to support MBC in routine clinical care for MDD within an outpatient psychiatric setting.

To determine both the clinical and practical utility of eMBC, this study will enroll "real-world" patients with few exclusion criteria and undergoing naturalistic treatments so that findings will be generalizable to other clinical settings and practices.

Note: As of April, 2020 (before recruitment started), because of the pandemic the study protocol was changed to be fully virtual, with a change in the primary outcome to a patient feasibility outcome.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Online eHealth Tool

Participants randomized to this group will use a personally-owned smartphone, tablet, or computer to access the online eHealth tool.

Group Type: EXPERIMENTAL

Online eHealth tool

Intervention Type: OTHER

Mobile-optimized online eHealth tool to support MBC.

Informational website (control)

Participants randomized to this group will receive information about online resources for mental health

Group Type: PLACEBO_COMPARATOR

Informational website

Intervention Type: OTHER

Participants randomized to this group will receive information about online resources for mental health

Interventions

Online eHealth tool

Mobile-optimized online eHealth tool to support MBC.

Intervention Type: OTHER

Informational website

Participants randomized to this group will receive information about online resources for mental health

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. age 19-65 and capable of informed consent;

2. diagnosis of major depressive episode (MDE) by the Diagnostic and Statistical Manual, Fifth Edition (DSM-5) criteria as determined by the clinic psychiatrist;

3. at least moderate depression as defined by QIDS-SR score of 10 or higher on the Quick Inventory for Depressive Symptomatology, Self-Rated (QIDS-SR);

4. access to an Internet-enabled computer or mobile device; and

5. able to read and understand English sufficiently to use the eMBC platform

Exclusion Criteria

1. active psychotic or substance use disorder; or

2. severe suicidality as judged by the psychiatrist.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vancouver Coastal Health Research Institute

OTHER

Sponsor Role: collaborator

Healthy Minds Canada

UNKNOWN

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Raymond Lam

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raymond W Lam, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

UBC Mood Disorders Centre

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

V17-02786

Identifier Type: OTHER

Identifier Source: secondary_id

H17-02786

Identifier Type: -

Identifier Source: org_study_id